CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 12 target
Drug / intervention
LCI699drug
Likely dose
LCI699 1 milligramfrom record
Key inclusion· 7
  • ✓Children and adolescents 2 to <18 years with endogenous Cushing's syndrome who have failed surgery, are awaiting surgery, or for whom surgery is not an immediate option
  • ✓Weight >10 kg
  • ✓Clinical evidence of Cushing's syndrome: decreasing growth percentiles with increasing weight, or strong clinical suspicion such as photographic change in facial appearance
  • ✓Abnormal low-dose dexamethasone suppression test with plasma cortisol >1.8 mcg/dl, or midnight serum cortisol >ULN, or late-night salivary cortisol >ULN
Key exclusion· 15
  • ✕Macroadenoma with compressive symptoms or at high risk for mass effect complications
  • ✕Insufficient washout from other cortisol-lowering medications (5 half-lives)
  • ✕Use of other investigational drugs within 30 days or 5 half-lives of the drug, whichever is longer
  • ✕History of hypersensitivity to osilodrostat or similar chemical classes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03708900
NCT03708900Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
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A Phase II, Multicenter, Open-label, Non-comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Osilodrostat in Children and Adolescent Patients With Cushing's Syndrome

RECORDATI GROUP·interventional·Posted Oct 17, 2018·Updated Mar 27, 2026

In Brief

A Phase 2 clinical trial evaluating LCI699 for Cushing Syndrome. Currently recruiting, targeting 12 participants across 15 sites in 7 countries.

Detailed Summary

Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing Syndrome
CountriesBelgium, Bulgaria, France, Italy, Slovenia, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
201920202021202220232024202520262027
First PostedOct 17, 2018
Enrollment StartApr 28, 2021
Primary CompletionJul 21, 2027
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 7.7 years agoPrimary completion in 1.1 years

Interventions

LCI699drug

osilodrostat (LCI699) is in the form of tablets 1 milligram (mg), 5 mg, and 10mg or in form of capsules 0.1 mg, 0.2 mg, 0.5 mg, 1 mg or 5 mg, both the formulations for oral administration